Knowledge Center

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: James Phillips, Consulting Manager, DSI, the Office of Data Standards and Interoperability, Franciscan Missionaries of Our Lady Health System (FMOLHS) CASE STUDY ORGANIZATION:

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: Jim Booker, Manager of Master Data Management, Supply Chain, Stanford Health Care CASE STUDY ORGANIZATION:

This Awareness Brief provides a high level summary understanding of value based purchasing. The Hospital Value Based Purchasing (VBP) Program adjusts hospitals’ payments based on their performance in four domains that reflect hospital cost, quality and outcomes. This calendar year, 2016, is the Performance Measurement Period for the FY 2018 VBP Program.

This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.

This learning lab covers alarm safety management in the health care supply chain field.

An announcement of the Final Rule issued by the IRS.

AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

The Medical Device Excise Tax, a component of the Affordable Care Act, is approaching implementation at the beginning of 2013. The tax is intended to provide an estimated $20 billion in tax revenues to help pay for the expansion of health coverage to 32 million uninsured Americans. Healthcare supply chain leaders have until May 7, 2012, to comment on the way in which the Internal Revenue Service (IRS) intends to implement this new tax.

The medical device excise tax is a feature of the Affordable Care Act. It is important to be knowledgeable about the tax and its effects.

New Guidance on Humidity Levels in the Operating Room

The Patient Protection and Affordable Care Act of 2010 (ACA) requires the Secretary of Health and Human Services to establish a VBP program to pay hospitals for their actual performance on quality measures, rather than just the reporting of those measures, beginning in fiscal year (FY) 2013. The VBP program will apply to all acute-care prospective payment system (PPS) hospitals. Read a summary of key provisions of the proposed rule.

Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.

The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:

The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.

This Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose dangers to patient safety.

AHRMM's Cost, Quality, and Outcomes (CQO) Movement will provide training and education to help supply chain professionals make the correlation between cost, quality, and outcomes.

How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision making.